Consultation on the HTA Documentary Framework for the Quality and Safety of Human Organs Intended for Transplantation
The HTA is consulting on the Framework documents ‘The Documentary Framework for the Quality and Safety of Human Organs Intended for Transplantation (‘the Framework’).
The Framework contains detailed information on the mandatory regulatory requirements as well as guidance on how those requirements may be met. Where appropriate the Framework also signposts the reader to other relevant legislation, codes of practice and guidance. The consultation, which is aimed at transplant centres and other interested parties, runs until Wednesday 21 December.
In implementing the Directive, the HTA and the Department of Health wish to ensure that the Regulations and Framework do not impose a greater regulatory burden on the UK than is required by the Directive (i.e. we do not wish to ‘gold plate’ the requirements of the Directive), nor put the UK at a disadvantage compared with other EU countries.
One of the key requirements of the Directive is that procurement organisations and transplantation centres, as defined by article 3 of the Directive, must be authorised by a competent authority. The Department of Health propose to implement this by requiring organisations that carry out procurement and transplantation activities to be licensed by the HTA.
We are therefore inviting your comments on this proposed approach to licensing and the other obligations we are placing on licensees. In particular, we wish to invite comments about how we can build on existing practices to minimise costs whilst achieving compliance with the Directive.
The Department of Health is undertaking a parallel consultation on the Regulations, and will be contacting stakeholders separately to seek comments. They are aiming to transpose the Directive by imposing minimum burdens on the procurement and transplantation sector, whilst continuing to ensure patient safety. This will be addressed in their consultation.
The specific HTA consultation questions are included in the draft Framework and in the pro-forma on the left. You can respond by using the form at the back of the document or the online version and returning it to the HTA either by email at: email@example.com or by post to:
Organ Donation Directive Consultation
Human Tissue Authority
151 Buckingham Palace Road